Virtual, blended inspections a sign of the times

Dr. Collins favors a tighter time frame. “I think it’s important not to drag this out. If it turns into a month-long inspection, you have defeated some of the benefits of this process.” He expects the process to become more standardized, whereby digital documents would be shared two weeks in advance of a virtual meeting, followed by an on-site visit within a day or two. “It keeps things nice and condensed and tight. The process moves along and people don’t grow weary of constant back and forth emails.”

• Luxury of flexibility. Having documents available within one’s own time frame was an advantage, Good says. “I could look at documents at 7 o’clock at night if I wanted,” she says. “I could go through things at my leisure and take notes.”

Dr. Collins says because documents could be reviewed in advance online, the on-site inspection his team conducted was less hurried and more manageable. “We had reviewed more detail prior, and we provided a better inspection because of it.”

Dr. Reineks saw things similarly during the inspections of the Cleveland Clinic labs. “The inspectors didn’t feel the constraints of sitting in a conference room with someone handing them materials. They probably felt the luxury of being able to go through documents completely and think about the various elements in them,” he says.

• Equally or more thorough. The inspectors and inspectees agree that hybrid inspections are as thorough as traditional on-site inspections. “After the CAP inspectors completed our virtual document assessment,” Dr. Reineks says, “they commented that it may have been the most thorough document inspection they had ever done.”

Good agrees: “I’ll take it one step further and claim that there is a more thorough review of documents when done in advance online, compared with reviews done during stressful on-site inspections.” After the Children’s inspection in Colorado, her team did another hybrid inspection. “That lab expressed concern we were too thorough,” she laughs.

• The more, the better. Being able to spread the work among a larger group of colleagues and use the effort to educate is the “big win,” Good says. “I was doing the general checklist and had someone with me who had never done the checklist before. So I let her ‘drive.’ She said, ‘Here are the questions I have based on the documents I’ve seen.’ As we talked through them, I could mentor her and make suggestions or point out fine points. There is a definite benefit to having others learn from the experience.”

Marrs, too, saw the upside of being able to bring in more people. “Usually when you are inspected you have a few point people. But in this format, when we were gathering our informational materials, we brought in new leads, new supervisors, and more staff to help support us and see how this all works. They had time to look and learn.”

Dr. Collins likes the collaboration: “The hybrid experience seems to drive a more consultative relationship between the peer lab inspection team and the labs being inspected.”

• Less stress, less disruption. Because document review takes place in advance of the hybrid and virtual inspections, on-site inspections often can be handled by one or two inspectors. “Their time on site can be shortened as well,” Dr. Reineks says. “The result is less disruption for the lab sending a team and for the lab being inspected. It also makes it more palatable for people to volunteer to do inspections if they are going to be away for only one day or night.”

Dr. Collins agrees that the new options are easier on the staff. “The number of people working in labs seems to get smaller even though volume goes up. Especially during COVID there have been issues with absences due to illness and increased testing coming in. We can’t spare as many people to go and do an inspection. These new options are less onerous.”

Says Malta: “Reducing size of the footprint of the on-site inspection team allows everyone to stay more focused. It’s better for everyone. It’s a win-win.”

Dr. Collins says he welcomes the opportunity to help fine-tune virtual inspections and remote document review. “When my team and I were on a lengthy ride home from an inspection, we brainstormed and made notes of recommendations,” he says. “We hope the CAP will take a strong role in standardizing this process—the way policies and procedures are uploaded, within a specified time frame, to a shared website monitored by the CAP. We also would encourage the CAP to be available to offer clarifications that may come up before or during the online inspection process, rather than wait until the on-site inspection.”

He and his team also believe that being able to review a laboratory’s proficiency testing and its CAP checklist book, online and in advance, would be of great benefit to the inspection team. “It would be ideal if they were uploadable and viewable in read-only form,” Dr. Collins says.

“It took a fair amount of work for my inspection team to coordinate our inspection because it was new to us. But with standardization it can go much quicker and more efficiently,” he says. “The CAP can make the difference by embracing the new formats so they become the new norm after the pandemic.”

Marrs and Good suggest that the CAP establish a standard virtual inspection process, complete with tools to allow documentation evidence to be tagged to a specific standard in question, a secure site for document submission and review, and smaller on-site inspection teams.

Such feedback has been instrumental in guiding the CAP to improve its inspection processes, Malta says. “We have been doing blended inspections since last summer. So last fall we did a survey of our labs and inspectors to find out how we can better support them.” Secure file sharing was a key concern, she says.

“We realized labs do not have a standard way to share their records. They expressed concerns about access to and the security of their documents. We offered a SharePoint site as an interim step and began building more functionality into the system and adding more security around the process.”

But SharePoint was always intended to be a temporary fix, Malta says. “We are implementing a more permanent solution, a standard platform. A lot of the feedback indicates this is something members want. We are in the process of making modifications to our ‘organization profile’ pages on the website, and building in a location for laboratories to upload documents during their reapplication process, giving them a significant amount of additional time to be able to get that done.” Laboratories can continue to make updates to those documents for up to four months before their anniversary date, she says. “The pressure to upload so many documents in a relatively short time was a major cause of hesitancy. This should relieve some of that.”

Phase-in of the improved organization profile functionality is set to begin in July. The CAP also plans to initiate an online deficiency response project downstream of the organization profile project.

What will remain of COVID-era inspections?

“I can’t say we have that completely worked out at this point,” Malta says. “But elements of the advance document review are likely to remain. It makes it easier to focus on the documentation, and then on-site time can be more purposeful. We’ve always tried to find a way to get inspectors out of the conference room, and this appears to be one effective solution.”

The processes and feedback from laboratories about these new approaches will continue to be assessed, says Council on Accreditation chair Dr. Scanlan. “The pandemic has offered us a chance to critically evaluate program delivery, just as we critically evaluate the accreditation checklists year over year.”

Dr. Reineks, for one, hopes the virtual and hybrid options are here to stay. “I don’t know if hybrid and virtual inspections would have been feasible even 10 years ago,” he says. “As times change we have to change with them, independent of the pandemic. I’m glad we now have this option.”

Marrs hopes laboratories will get into the hybrid and virtual stride sooner rather than later.

”There’s no way around this. We still need to do inspections during this pandemic. We still need to have that second pair of eyes looking at our policies and processes,” she says. “We need to do it for accreditation. But even more important, we need to do it because we always come out a better lab on the other end.”

Valerie Neff Newitt is a writer in Audubon, Pa.